Generic Product News: March

Pharmacy TimesMarch 2023
Volume 89
Issue 3

Products include oral suspension for gout and tablets that prevent low carnitine levels in the blood.

Naproxen, 125 mg/5 mL

From: Camber Pharmaceuticals

Compare To: Naprosyn

Camber Pharmaceuticals recently introduced a nonsteroidal anti inflammatory drug (NSAID) to a growing lineup of generic products. Naproxen oral suspension, available in a 125-mg/5-mL strength and administered in a 500-mL bottle, is the generic formulation to the reference listed drug, Naprosyn from Dr. Reddy’s Laboratories Ltd. Naproxen oral suspension should be used to manage pain and primary dysmenorrhea. It is indicated to treat an array of symptoms, including acute gout, ankylosing spondylitis, bursitis, osteoarthritis, polyarticular juvenile idiopathic arthritis, tendonitis, and rheumatoid arthritis. Common adverse events of NSAIDs include constipation, diarrhea, dizziness, and stomach pain. Higher-grade adverse events have also been reported.

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Fluoxetine Oral Solution, USP, 20 mg/5 mL

From: ANI Pharmaceuticals, Inc

Compare To: Prozac

ANI Pharmaceuticals, Inc, recently announced that the FDA approved its abbreviated new drug application for fluoxetine oral solution USP, 20 mg/5 mL. The generic version of reference listed drug (RLD) Prozac from Eli Lilly and Company is indicated to manage depression. The market for fluoxetine oral solution is more than $14 million annually, according to analytics provider IQVIA/IMS Health. The most common adverse events listed for the RLD include anxiety, nausea, and nervousness.

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Levocarnitine Tablets USP, 330 mg

From: ANI Pharmaceuticals, Inc

Compare To: Carnitor

The FDA has approved ANI Pharmaceuticals, Inc’s abbreviated new drug application for levocarnitine tablets USP, 330 mg. Levocarnitine is a supplement that helps prevent low levels of carnitine in the blood, especially in patients with kidney disease who are on dialysis. Carnitine helps the body use long-chain fatty acids for energy. The most common adverse events include body odor, headaches, nausea, swelling of the feet and hands, upset stomach, and vomiting. The US market for levocarnitine tablets is valued at approximately $10 million, according to IQVIA/IMS Health.

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Levomilnacipran Extended-Release Capsules, 20, 40, 80, and 120 mg

From: Zydus Pharmaceuticals, Inc

Compare To: Fetzima

The FDA has granted the US arm of Zydus Lifesciences tentative approval to market levomilnacipran extended-release capsules in strengths of 20, 40, 80, and 120 mg. Levomilnacipran extended-release capsules act as a serotonin and norepinephrine reuptake inhibitor and are indicated to manage major depressive disorder in adults, according to Zydus. The capsules are the generic form of Fetzima. This drug was originally developed in France and licensed to a US laboratory called Forest Laboratories, but that company stopped its operation in 2014. Annual sales in the United States for levomilnacipran capsules reached $85 million in 2022, according to estimates from the IQVIA.

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